Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer, who is our principal
executive officer, and our Chief Financial Officer, who is our principal financial officer, evaluated the effectiveness of our disclosure
controls and procedures as of December 31, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e)
and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required
to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within
the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or
submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial
Officer, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer and our Chief
Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2022.
Management’s Annual Report on Internal Control Over Financial
Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange
Act). Our Chief Executive Officer and our Chief Financial Officer assessed the effectiveness of our internal control over financial reporting
as of December 31, 2022. In making this assessment, our Chief Executive Officer and our Chief Financial Officer used the criteria
set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control—Integrated Framework.
Based on that assessment and using the COSO criteria, our Chief Executive Officer and our Chief Financial Officer have concluded that,
as of December 31, 2022, our internal control over financial reporting was effective.
Our independent registered public accounting firm
will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are an
“emerging growth company” pursuant to the provisions of the Jumpstart Our Business Startups Act.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control
over financial reporting during the year ended December 31, 2022, that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
Inherent Limitations of Controls
Management does not expect that our disclosure
controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. Controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management
necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making
can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls
also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes
in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud may occur and not be detected.
ITEM 9B. OTHER INFORMATION
Not applicable.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
INSPECTIONS
Not applicable.
32
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2022.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2022.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN
BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2022.
Securities Authorized for Issuance under Equity Compensation Plans
The following table sets forth information regarding
our equity compensation plans at December 31, 2022:
Plan category
Number of securities to be
issued upon
exercise of
outstanding
options,
warrants and
rights
(a)
Weighted-
average exercise price
of
outstanding
options,
warrants and
rights
(b)
Number of securities
(by class) remaining
available for future
issuance under
equity compensation
plans (excluding
securities reflected in
column (a))
(c)
Equity compensation plans approved by security holders (1)
719,835
$ 1.96
1,601,990
Equity compensation plans not approved by security holders (2)
559,599
$ 4.20
-
(1) Represents shares of common stock
issuable upon exercise of outstanding stock options and rights under our 2018 Stock Incentive Plan (the “2018 Plan”) and
2021 Stock Plan (the “2021 Plan”). Both plans permit the Company to grant incentive and nonqualified stock options for the
purchase of common stock, and restricted stock awards. The maximum number of shares of common stock reserved for issuance under the 2018
Plan and 2021 Plan are 629,440 and 1,960,000, respectively. At December 31, 2022 there were 262,269 and 1,339,721 shares of common stock
available for grant under the 2018 Plan and 2021 Plan, respectively.
(2) Consists of warrants issued to
placement agents, underwriters and consultants.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2022.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item is hereby
incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within
120 days of the fiscal year ended December 31, 2022.
33
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part
of this report:
(1) Financial Statements—See
Index to Consolidated Financial Statements at Part II, Item 8 on page F-1 of this Form 10-K.
(2) All financial statement schedules
have been omitted because they are not applicable or not required or because the information is included elsewhere in the financial statements
or the Notes thereto.
(3) See the accompanying Index to
Exhibits filed as a part of this Form 10-K, which list is incorporated by reference in this Item.
(b) See the accompanying Index to Exhibits filed
as a part of this Form 10-K.
(c) Other schedules are not applicable.
34
INDEX TO EXHIBITS
Exhibit No.
Description of Document
3.1
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
3.2
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.1
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.2
Form of Class A Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K (File No. 001-41031), filed on November 16, 2021).
4.3
Form of Class B Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.4
Form of Warrant Agency Agreement (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.5
Form of IPO Underwriters’ Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
4.6
Description of Securities of Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 4.6 to the Company’s annual report on Form 10-K for the year ended December 31, 2021.
10.1**
2021 Stock Plan (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.2
License and Supply Agreement, dated October 6, 2020, by and between Toray Industries, Inc. and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.3**
Employment Agreement, dated July 1, 2021, between Neil Dey and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.4**
Employment Agreement, dated July 1, 2021, between Gordon Kinder and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.5**
Employment Agreement, dated July 1, 2021, between Jason Cook and Bluejay Diagnostics, Inc.* (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.6**
Employment Agreement, dated July 1, 2021, between Kevin Vance and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.7
Securities Purchase Agreement, dated June 7, 2021, between certain purchasers and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.8
Registration Rights Agreement, dated June 7, 2021, between certain purchasers and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.9
Amendment to License and Supply Agreement, dated July 21, 2021, by and between Toray Industries, Inc. and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
10.10**
First Amendment to Employment Agreement, dated January 27, 2023, between Neil Dey and Bluejay Diagnostics, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-41031), filed on January 27, 2023).
14.1
Code of Ethics (incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company’s Registration Statement on Form S-1 (File No. 333-260029), filed on October 4, 2021).
31.1*
Certification of Principal Executive Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
31.2*
Certification of Principal Financial Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended
32.1*
Certification of Principal Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*
Certification of Principal Financial Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (formatted as Inline XBRL and included in Exhibit 101)
* Filed
herewith.
** Management
contract or compensatory plan, contract or arrangement.
ITEM 16. FORM 10-K SUMMARY.
None.
35
SIGNATURES
Pursuant to the requ irements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized on March 20, 2023.
Bluejay Diagnostics, Inc.
By:
/s/ Neil Dey
Neil Dey
Chief Executive Officer and Director
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Neil Dey
Director and Chief Executive Officer
March
20, 2023
Neil Dey
(Principal Executive Officer)
/s/
Kenneth Fisher
Chief
Financial Officer
March
20, 2023
Kenneth Fisher
(Principal Financial and Accounting Officer)
/s/
Douglas C. Wurth
Chairman of the Board of Directors
March 20, 2023
Douglas C. Wurth
/s/
Donald R. Chase
Director
March 20, 2023
Donald R. Chase
/s/ Svetlana
Dey
Director
March
20, 2023
Svetlana Dey
/s/ Fred
S. Zeidman
Director
March 20, 2023
Fred S. Zeidman
/s/
Gary Gemignani
Director
March
20, 2023
Gary Gemignani
36
Index to Consolidated Financial Statements
Contents
Report of Independent Registered Public Accounting Firm (PCAOB ID # 392 ) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations F-4
Consolidated Statements in Redeemable Preferred Stock and Stockholders’ Equity (Deficit) F-5
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7
F- 1
Report
of Independent Registered Public Accounting Firm
Report of Independent Registered Public Accounting
Firm
To the Shareholders and the Board of Directors of Bluejay Diagnostics,
Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Bluejay Diagnostics, Inc. (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations,
stockholders’ equity (deficit) and cash flows for the years then ended, and the related notes to the consolidated financial statements
(collectively, the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years
then ended, in conformity with accounting principles generally accepted in the United States of America.
Uncertainty Relating to Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has
incurred net losses since its inception, and has negative cash flows from operations and will need additional funding to complete planned
development efforts. This raises substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard
to these matters also are described in Note 1. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Wolf & Company, P.C.
Wolf & Company, P.C.
We have served as the Company's auditor since 2017.
Boston, Massachusetts
Mar ch 20, 20 23
F- 2
Bluejay Diagnostics, Inc.
Consolidated Balance Sheets
December 31,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$ 10,114,990
$ 19,047,778
Prepaid expenses and other current assets
1,673,480
1,612,708
Total current assets
11,788,470
20,660,486
Property and equipment, net
1,232,070
337,366
Operating lease right-of-use assets
465,514
-
Other non-current assets
35,211
21,019
Total assets
$ 13,521,265
$ 21,018,871
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 635,818
$ 295,778
Operating lease liability, current
168,706
-
Accrued expenses and other current liabilities
835,730
341,384
Total current liabilities
1,640,254
637,162
Operating lease liability, non-current
323,915
-
Other non-current liabilities
15,823
-
Total liabilities
1,979,992
637,162
Commitments and Contingencies (See Note 13)
Stockholders’ equity:
Common stock, $ 0.0001 par value; 100,000,000 shares authorized; 20,215,288 and 20,112,244 shares issued and outstanding at December 31, 2022 and 2021, respectively
2,022
2,011
Additional paid-in capital
28,536,353
28,074,484
Accumulated deficit
( 16,997,102 )
( 7,694,786 )
Total stockholders’ equity
11,541,273
20,381,709
Total liabilities and stockholders’ equity
$ 13,521,265
$ 21,018,871
See notes to consolidated financial statements.
F- 3
Bluejay Diagnostics, Inc.
Consolidated Statements of Operations
For the Years Ended
December 31,
2022
2021
Revenue
$ 249,040
$ -
Cost of sales
200,129
-
Gross profit
48,911
-
Operating expenses:
Research and development
4,152,152
1,147,955
General and administrative
4,763,114
1,792,482
Marketing and business development
451,421
289,726
Total operating expenses
9,366,687
3,230,163
Operating loss
( 9,317,776 )
( 3,230,163 )
Other income (expense):
Interest expense, net of amortization of premium
-
( 367,459 )
Impairment of property and equipment
( 237,309 )
-
State grant income
-
75,000
Other income, net
258,137
34,324
Total other income (expense), net
20,828
( 258,135 )
Net loss
$ ( 9,296,948 )
$ ( 3,488,298 )
Net loss per share - Basic and diluted
$ ( 0.46 )
$ ( 0.41 )
Weighted average common shares outstanding:
Basic and diluted
20,163,915
8,522,422
See notes to consolidated financial statements.
F- 4
Bluejay Diagnostics, Inc.
Statements of Changes in Redeemable Preferred
Stock and Stockholders’ Equity (Deficit)
Redeemable,
Convertible Preferred Stock
Stockholders’
Equity (Deficit)
Additional
Total
Stockholder’s
Series
A
Series
B
Series
C
Series
D
Common
Stock
Paid-In
Accumulated
Equity
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Balance at December 31,
2020
10,600
$ 1,077,303
5,187
$ 1,800,347
636
$ 1,000,465
3,147,200
$ 315
$ -
$ ( 4,206,488 )
$ ( 4,206,173 )
Exercise of common stock warrants
-
-
-
-
-
-
-
-
4,715,836
471
140,990
-
141,461
Accretion of redeemable,
convertible preferred stock to redemption value
-
73,912
-
33,994
19,961
-
-
-
-
( 127,866 )
-
( 127,866 )
Conversion of convertible
debentures into Series D preferred stock
-
-
-
-
-
-
4,500
4,036,535
-
-
-
-
Conversion of redeemable,
convertible preferred stock into common stock
( 10,600 )
( 1,151,215 )
( 5,187 )
( 1,834,341 )
( 636 )
( 1,020,426 )
( 4,500 )
( 4,036,535 )
7,084,323
708
8,041,809
-
8,042,517
Fair value of warrants issued
for services
-
-
-
-
-
-
-
-
-
-
180,339
-
180,339
Fair value of warrants issued
to placement agent in relation to the Convertible debentures
-
-
-
-
-
-
-
-
-
166,816
166,816
Conversion of Amended 2017
Convertible Notes into common stock
-
-
-
-
-
-
-
-
580,000
58
579,942
-
580,000
Reclassification of Series
B Warrants
-
-
-
-
-
-
-
-
-
-
145,953
-
145,953
Stock-based compensation
expense
-
-
-
-
-
-
-
-
-
-
68,458
-
68,458
Issuance of common stock
from exercise of stock options
-
-
-
-
-
-
-
-
56,385
6
22,617
-
22,623
Issuance of common stock in initial public offering, net of offering costs of $ 2,750,601
-
-
-
-
-
-
-
-
2,160,000
216
18,855,663
-
18,855,879
Issuance of common stock
from exercise of warrants
-
-
-
-
-
-
-
-
2,368,500
237
( 237 )
-
-
Net
loss
-
-
-
-
-
-
-
-
-
( 3,488,298 )
( 3,488,298 )
Balance
at December 31, 2021
-
$ -
-
$ -
-
$ -
-
20,112,244
$ 2,011
$ 28,074,484
$ ( 7,694,786 )
$ 20,381,709
Impact of adoption of ASC 842
-
-
-
-
-
-
-
-
-
-
-
( 5,368 )
( 5,368 )
Stock-based compensation
expense
-
-
-
-
-
-
-
-
-
-
433,004
-
433,004
Exercise of stock options
-
-
-
-
-
-
-
-
62,944
7
28,869
-
28,876
Exercise of common stock
Series B Warrants
-
-
-
-
-
-
-
-
40,100
4
( 4 )
-
-
Net
loss
-
-
-
-
-
-
-
-
-
( 9,296,948 )
( 9,296,948 )
Balance
at December 31, 2022
-
$ -
-
$ -
-
$ -
-
20,215,288
$ 2,022
$ 28,536,353
$ ( 16,997,102 )
$ 11,541,273
See notes to consolidated financial statements.
F- 5
Bluejay Diagnostics, Inc.
Consolidated Statements of Cash Flows
For the Year Ended
December 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Loss
$ ( 9,296,948 )
$ ( 3,488,298 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
156,598
145,719
Stock-based compensation expense
433,004
68,458
Amortization of right-of-use assets
149,770
-
Impairment of property and equipment
237,309
-
Loss on disposal of property and equipment
137
-
Issuance of warrants for service
-
180,339
Gain on forgiveness of note payable, Paycheck Protection Program
-
( 5,000 )
Non-cash interest expense
-
227,007
Gain on revaluation of derivative warrant liability
-
( 9,676 )
Changes in operating assets and liabilities:
Inventory
-
84,762
Prepaid expenses and other current assets
( 40,772 )
( 1,551,637 )
Non-current assets
( 14,192 )
( 21,019 )
Accounts payable
298,881
( 79,150 )
Due to related party
( 2,000 )
( 123,102 )
Accrued expenses
336,620
204,839
Net cash used in operating activities
( 7,741,593 )
( 4,366,758 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 1,199,270 )
( 23,947 )
Net cash used in investing activities
( 1,199,270 )
( 23,947 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments of principal on notes payable
-
( 289,617 )
Payments of convertible debenture issuance costs
-
( 562,842 )
Proceeds from initial public offering, net of offering costs
-
18,855,879
Proceeds from issuance of convertible debentures
-
4,500,000
Payments on note payable, Paycheck Protection Program
-
( 9,000 )
Proceeds from exercise of common stock warrants
-
9,079
Payments of deferred offering costs
( 20,000 )
-
Payment of finance lease
( 801 )
-
Proceeds from exercise of stock options
28,876
22,623
Net cash provided by financing activities
8,075
22,526,122
(Decrease) increase in cash and cash equivalents
( 8,932,788 )
18,135,417
Cash and cash equivalents, beginning of year
19,047,778
912,361
Cash and cash equivalents, end of year
$ 10,114,990
$ 19,047,778
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH FINANCING ACTIVITIES
Interest paid
$ 364
$ 150,228
Accretion of Series A redeemable, convertible preferred stock dividend
$ -
$ 17,667
Accretion of Series A redeemable, convertible preferred stock issuance costs and fair value adjustment
$ -
$ 56,245
Accretion of Series B redeemable, convertible preferred stock dividend
$ -
$ 31,258
Accretion of Series B redeemable, convertible preferred stock issuance costs
$ -
$ 2,736
Accretion of Series C redeemable, convertible preferred stock dividend
$ -
$ 16,727
Accretion of Series C redeemable, convertible preferred stock issuance costs
$ -
$ 3,234
Exercise of warrants through debt principal conversion
$ -
$ 132,383
Conversion of convertible debentures into preferred stock
$ -
$ 4,500,000
Conversion of preferred stock into common stock
$ -
$ 8,505,982
Conversion of amended 2017 convertible notes
$ -
$ 580,000
Reclassification of derivative warrant liability into additional paid-in capital
$ -
$ 145,953
Fair value of warrants issued to placement agent in relation to the Convertible debentures
$ -
$ 166,816
Fair value of warrants for common stock issued for services
$ -
$ 180,339
Fair value of warrants issued to underwriters
$ -
$ 2,939,327
Liabilities incurred for the purchase of property and equipment
$ 41,159
$ -
See notes to consolidated financial statements.
F- 6
Bluejay Diagnostics, Inc.
Notes to the Consolidated Financial Statements
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Bluejay Diagnostics, Inc. (“Bluejay”
and/or the “Company”) is a medical diagnostics company developing rapid tests using whole blood on our Symphony technology
platform (“Symphony”) to improve patient outcomes in critical care settings. The Company’s Symphony platform is a combination
of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP that consists of a mobile device
and single-use test cartridges that if cleared, authorized, or approved by the U.S. Food and Drug Administration (the “FDA”),
can provide a solution to a significant market need in the United States. Clinical trials indicate the Symphony device produces laboratory-quality
results in less than 20 minutes in critical care settings, including Intensive Care Units (“ICUs”) and Emergency Rooms (“ERs”),
where rapid and reliable results are required.
Bluejay’s first product, the Symphony IL-6
test, is for the monitoring of disease progression in critical care settings. IL-6 is a clinically established inflammatory biomarker,
considered a ‘first-responder,’ for assessment of severity of infection and inflammation across many disease indications,
including sepsis. A current challenge of healthcare professionals is the excessive time and cost associated determining a patient’s
level of severity at triage and the Symphony IL-6 test has the ability to consistently monitor this critical care biomarker with rapid
results.
In the future Bluejay plans to develop additional
tests for Symphony including two cardiac biomarkers (hsTNT and NT pro-BNP) as well as other tests using the Symphony platform. The Company
does not yet have regulatory clearance for its Symphony products, and its Symphony products will need to receive regulatory authorization
from the FDA in order to be marketed as a diagnostic product in the United States.
Bluejay’s operations to date have been funded
primarily through the proceeds of the Company’s initial public offering (the “IPO”) in November 2021 (the “IPO
Date”).
On June 4, 2021, the Company formed Bluejay Spinco, LLC, a wholly-owned
subsidiary of the Company, for purposes of further development of the Company’s ALLEREYE diagnostic test. ALLEREYE is a point-of-care
device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis.
Initial Public Offering
The Company completed its initial public
offering (the “IPO”) in November 2021 (“IPO Date”), whereby it sold 2,160,000 Units at a price of $10.00, with
each Unit consisting of one share of the Company’s common stock, one warrant to purchase one share of common stock at an exercise
price of $7.00 per share (“Class A Warrant”), and one warrant to purchase one share of common stock at an exercise price of
$10.00 (“Class B Warrant”) (collectively, a “Unit”). Each warrant contained within the Units is exercisable until
the fifth anniversary of the IPO Date, however, holders of Class B Warrants may exercise such warrants on a “cashless” basis
after the earlier of (i) 10 trading days from closing date of the offering or (ii) the time when $10.0 million of volume is traded in
the Company’s common stock, if the volume weighted average price of the Company’s common stock on any trading day on or after
the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to adjustment as described in the
warrant agreement). Additionally, the underwriter of the IPO exercised their overallotment option, solely with respect to the Class A
Warrants and Class B Warrants, shortly after the IPO Date which resulted in an additional issuance of 324,000 Class A Warrants and 324,000
Class B Warrants. The gross proceeds from the IPO were approximately $21.6 million and were offset by $2.8 million in offering costs.
F- 7
Risks and Uncertainties
The Company is subject to a number of risks similar
to other companies in its industry, including rapid technological change, competition from larger biotechnology companies and dependence
on key personnel. The Company is also impacted by inflationary pressures and global supply chain disruptions currently impacting many
companies.
On October 25, 2022,
the Company received a notification letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”)
notifying the Company that the closing bid price for its common stock had been below $ 1.00 for the previous 30 consecutive business days
and that the Company therefore is not in compliance with the minimum bid price requirement for continued inclusion on the Nasdaq Capital
Market under Nasdaq Listing Rule 5550(a)(2). The notification has no immediate effect on the listing of the Company’s common stock
on the Nasdaq Capital Market. The Company intends to take all reasonable measures available to achieve compliance and allow for continued
listing on the Nasdaq Capital Market. However, there can be no assurance that the Company will be able to regain compliance with the minimum
bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.
Going Concern
The Consolidated Financial Statements for the
years ended December 31, 2022 and 2021 were prepared under the assumption that the Company will continue as a going concern, which contemplates
that the Company will be able to realize assets and discharge liabilities in the normal course of business. However, the Company has incurred
net losses since its inception, and has negative cash flows from operations and will need additional funding to complete planned development
efforts. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
The Company had cash and cash equivalents of $ 10.1 million at December
31, 2022. It continues to develop the Symphony device and its first test for the measurement of IL-6. It remains committed to obtaining
FDA clearance and has expanded clinical trials to obtain additional data to support its de novo FDA submission, while also continuing
to build its manufacturing operations with its CMOs. Current cash resources and expected operating expenses are considered in determining
its liquidity requirement; as well as $ 1.6 million of current liabilities on its balance sheet at December 31, 2022 and capital commitments
of approximately $ 2 million during 2023 (see Notes 12 and 13). Given the Company’s current plans, the Company estimates cash resources
will be sufficient to fund its operations through the fourth quarter of 2023. The Company will need additional capital to fund its planned
operations for the next 12 months.
The Company may seek to raise such additional
capital through public or private equity offerings, grant financing and support from governmental agencies, convertible debt, collaborations,
strategic alliances and distribution arrangements. Additional funds may not be available when it needs them on terms that are acceptable
to them, or at all. If adequate funds are not available, it may be required to delay or reduce the scope of its research or development
programs, its commercialization efforts or its manufacturing commitments and capacity. In addition, if it raises additional funds through
collaborations, strategic alliances or distribution arrangements with third parties, it may have to relinquish valuable rights to its
technologies or future revenue streams.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements
have been prepared in accordance with U.S. generally accepted accounting principles in the United States (“GAAP”) and include
all adjustments necessary for the presentation of the Company’s consolidated financial position, results of operations and cash
flows for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.
All intercompany balances and transactions have been eliminated in consolidation.
On June 7, 2021, the Company’s Board
of Directors declared a stock dividend of 2.15 shares of common stock for every share of common stock. This stock dividend was deemed
a large stock dividend and was treated as a 1-for-3.15 stock split. The common stock shares and per share amounts (other than authorized
shares) in these consolidated financial statements and related notes have been retroactively restated to reflect the stock dividend for
all periods presented.
F- 8
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in these condensed consolidated
financial statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment
is involved in accounting for the fair value-based measurement of stock-based compensation, accruals, convertible notes and warrants.
The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined
with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the condensed
consolidated financial statements.
Financial Statement Reclassifications
Certain balances in the prior year consolidated
financial statements have been reclassified to conform to the presentation in the current year consolidated financial statements.
Cash and Cash Equivalents
The Company considers all highly liquid investments
with maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents, consisting of highly liquid
money market are carried at fair market value which approximates cost.
Revenue Recognition
The Company recognizes revenue under the core
principles of depicting the transfer of control to the Company’s customers in an amount reflecting the consideration to which the
Company expected to be entitled. In order to achieve that core principle, the Company applies the following five step approach: (1) identify
the contract with a customer, (2) identify the performance obligations in that contract, (3) determine the transaction price, (4) allocate
the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied.
The Company recognizes revenue when performance
obligations under the terms of the contract with the customer are satisfied and are recognized at a point in time, which is also when
control is transferred. When the Company performs shipping and handling activities after the transfer of control to the customer (e.g.
when control transfers prior to delivery), they are considered fulfillment activities and, accordingly, the costs are accrued for when
the related revenue is recognized. Sales tax and valued added taxes collected from the customers relating to product sales and remitted
to governmental authorities are excluded from revenues.
Leases
Effective January 1, 2022, the Company adopted
the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) ASC 842, Leases
(“ASC 842”). The Company has adopted ASC 842 using the optional transition method and, as a result, there have been no reclassification
of prior comparable periods due to this adoption.
The Company has arrangements involving the lease
of facilities. Under ASC 842, at inception of the arrangement, the Company determines whether the contract is or contains a lease and
whether the lease should be classified as an operating or a financing lease. This determination, among other considerations, involves
an assessment of whether the Company can control the underlying asset and have the right to obtain substantially all to the economic benefits
or outputs from the asset.
F- 9
The Company recognizes right-of-use (“ROU”)
assets and lease liabilities as of the lease commencement date based on the net present value of the future minimum lease payments over
the lease term. ASC 842 requires the leases to use the rate implicit in the lease unless it is not readily determinable and then it may
use its incremental borrowing rate (“IBR”) to discount the future minimum lease payments. Most of the Company’s leases
do not provide an implicit rate; therefore, the Company uses its IBR to discount the future minimum lease payments. The Company determines
its IBR with its credit rating and other economic information available as of the commencement date, as well as the identified lease term.
During the assessment of the lease term, the Company considers its renewal options and extensions within the arrangements and the Company
includes these options when it’s reasonably certain to extend the term of the lease.
The Company leases include both lease and non-lease
components. Consideration is allocated to the lease and non-lease components based on estimated standalone prices. The Company has elected
to exclude non-lease components from the calculation of its ROU assets and lease liabilities.
The Company has lease arrangements that contain
incentives for tenant improvements as well as fixed rent escalation clauses. For contracts with tenant improvement incentives that are
determined to be leasehold improvements and the Company is reasonably certain to exercise, it records a reduction to the lease liability
and amortizes the incentive over the identified term of the lease as a reduction to rent expense. The Company records rental expense on
a straight-line basis over the identified lease term on contracts with rent escalation clauses.
Finance leases are not material to the Company’s
consolidated financial statements.
Concentration of Credit Risk
Cash, and cash equivalents consist of financial
instruments that potentially subject the Company to a concentration of credit risk in the event of a default by the related financial
institution holding the securities, to the extent of the value recorded in the balance sheet. The Company invests cash that is not required
for immediate operating needs primarily in highly liquid instruments with lower credit risk.
Research and Development Expenses
Costs incurred in the research and development
of new products are expensed as incurred. Research and development costs include, but are not limited to, salaries, benefits, stock-based
compensation, laboratory supplies, fees for professional service providers and costs associated with product development efforts, including
preclinical studies and clinical trials. As of December 31, 2022 and 2021, respectively, the Company had $ 371,000 and $ 0 capitalized in
property and equipment related to pre-production molds and tooling related to the Symphony device.
The Company estimates preclinical study and clinical
trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that
conduct and manage preclinical studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period
over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of
services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Payments made to third parties
under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses until the services are rendered.
Stock-Based Compensation
Share-based compensation expense for all
share-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award.
Share-based compensation expense for awards granted to non-employees is determined using the fair value of the consideration received
or the fair value of the equity instruments issued, whichever is more reliably measured.
The Company uses the Black-Scholes option pricing
model to determine the fair value of options granted. The Company recognizes the compensation cost of share-based awards on a straight-line
basis over the requisite service period. For stock awards for which vesting is subject to performance – based milestones, the expense
is recorded over the implied service period after the point when the achievement of the milestone is probable, or the performance condition
has been achieved.
F- 10
The determination of the fair value of share-based
payment awards utilizing the Black-Scholes model is affected by the stock price and a number of assumptions, including expected volatility,
expected life, risk-free interest rate and expected dividends. The Company does not have a history of market prices of its common stock,
and as such, volatility is estimated using historical volatilities of similar public entities. The expected life of the awards is estimated
based on the simplified method for grants to employees and is based on the contractual term for non-employee awards. The risk-free interest
rate assumption is based on observed interest rates appropriate for the terms of the awards. The dividend yield assumption is based on
history and expectation of paying no dividends.
The Company recognizes forfeitures related to
employee share-based payments when they occur. Forfeited share-based awards are recorded as a reduction to stock compensation expense.
Segment Reporting
Management has determined that the Company has
one operating segment, which is consistent with the Company structure and how it manages the business.
Income Taxes
The Company follows accounting guidance regarding
the recognition, measurement, presentation and disclosure of uncertain tax positions in the consolidated financial statements. Tax positions
taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether
the tax positions are “more-likely-than-not” of being sustained by the applicable tax authorities. Tax positions not deemed
to meet a more-likely-than-not threshold would be recorded in the consolidated financial statements. There are no uncertain tax positions
that require accrual or disclosure as of December 31, 2022. Any interest or penalties are charged to expense. During the years ended December
31, 2022 and 2021, the Company had no significant interest and penalties. Tax years subsequent to December 31, 2018 are subject to examination
by federal and state authorities.
The Company recognizes deferred tax assets and
liabilities based on the impact of temporary differences between assets and liabilities recognized for tax and financial reporting purposes
measured by applying enacted tax rates and laws that will be in effect when the differences are expected to reverse, net operating loss
carryforwards and tax credits. Valuation allowances are provided when necessary to reduce net deferred tax assets to an amount that is
more likely than not to be realized. The deferred tax benefit or expense for the period represents the change in the deferred tax asset
or liability from the beginning to the end of the period.
Net Loss per Share
Basic net loss per share is computed by dividing
the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potentially
dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common
stock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods. Dilutive
common stock equivalents are comprised of convertible preferred stock, convertible notes, options outstanding under the Company’s
stock option plan and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and
diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.
Potentially dilutive securities not
included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent
shares):
December 31
2022
2021
Options to purchase common stock
719,835
503,433
Warrants for common stock
811,882
811,882
Class A Warrants for common stock
2,484,000
2,484,000
Class B Warrants for common stock
75,400
115,500
F- 11
Recently Adopted Accounting Standards
In February 2016, the FASB issued Accounting Standards
Update (“ASU”) 2016-02, Leases. The new guidance requires the recognition of lease liabilities, representing future
minimum lease payments, on a discounted basis, and corresponding right-of-use assets on a balance sheet for most leases, along with requirements
for enhanced disclosures to give financial statement users the ability to assess the amount, timing, and uncertainty of cash flows arising
from leasing arrangements. The Company adopted the provisions of ASU 2016-02 on January 1, 2022 and elected to implement the transition
package of practical expedients permitted within the new standard, which included (i) not reassessing whether expired or existing contract
contain leases, (ii) not reassessing lease classification, and (iii) not revaluing initial direct costs for existing leases. Adoption
of the new standard resulted in the recording of initial right-of-use assets and lease liabilities of approximately $ 200,000 as of January
1, 2022. The new standard did not materially impact the Company’s consolidated statements of operations or cash flows.
In May 2021, the FASB issued ASU
2021-04 Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock
Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues
Task Force) . The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021,
including interim periods within those fiscal years. Early application is permitted, including in an interim period as of the beginning
of the fiscal year that includes that interim period. The adoption date of this ASU did not have a material impact on the Company’s
financial position and results of operations.
Recently Issued Accounting Standards
In October 2021, the FASB issued ASU No. 2021-08,
Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“ASU
805”) , an amendment of the ASC. The amendments to ASU 805 address diversity and inconsistency related to the recognition and
measurement of contract assets and contract liabilities acquired in a business combination and require that an acquirer recognize and
measure contract assets and contract liabilities acquired in accordance with ASC 2014-09, Revenue from Contracts with Customers (Topic
606) (“ ASC 606”). Under GAAP, an acquirer generally recognizes assets and liabilities assumed in a business combination,
including contract assets and liabilities arising from revenue contracts with customers, at fair value on the acquisition date. ASU No.
2021-08 will result in the acquirer recording acquired contract assets and liabilities on the same basis that would have been recorded
by the acquiree before the acquisition under ASC 606. This ASU is effective for fiscal years beginning after December 15, 2022, with early
adoption permitted, including adoption in an interim period. The Company is currently evaluating the effect that this standard may have
on its financial position and related disclosures.
3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES
On October 6, 2020, the Company entered
into a License and Supply Agreement (“License Agreement”) with Toray Industries, Inc. (“Toray”). Under the License
Agreement, the Company received the exclusive license (outside of Japan) to make and distribute protein detection cartridges that have
a function of automatic stepwise feeding of reagent (the “Cartridges”). In exchange for the license, the Company committed
to make two payments of $ 120,000 each, both of which were made in 2021. In addition, following the first sale of the Cartridges after
regulatory approval, the Company will make royalty payments to Toray equal to 15 % of the net sales of the Cartridges for the period that
any underlying patents exist or five years after the first sale. Following the first sale after obtaining regulatory approval, the Company
will make minimum annual royalty payments of $ 60,000 for the first year and $ 100,000 for each year thereafter, which shall be creditable
against any royalties owed to Toray in such calendar year. There were no sales of or revenues from the Cartridges during the 12-month
periods ended December 31, 2022 and 2021.
At December 31, 2022 and 2021, there
were no amounts accrued related to the License Agreement.
F- 12
4. NOTES PAYABLE
2017 Notes Payable
In 2017, the Company entered into multiple
Unit Purchase Agreements (the “Financing”) whereby the Company issued 106 Units. Each Unit consisted of 100 shares of Series
A redeemable, convertible preferred stock (“Series A”) at a purchase price of $100 per share and $10,000 in notes payable
(the “Notes”). The Company defaulted on certain Notes issued in 2017 with aggregate principal amount of $ 1,060,000 in January
2021. On February 17, 2021, the Company repaid in cash $ 268,000 in principal and $ 2,010 in accrued interest on the Notes. On May 26, 2021,
the remaining Notes of $ 580,000 were amended and restated (the “Amended Notes”). The Amended Notes accrue no interest and
were due in May 2023. On June 8, 2021, the Amended Notes were automatically convertible into 580,000 shares of common stock at the conversion
rate of $ 1.00 per share upon the issuance by the Company of securities to Sabby Volatility Warrant Master Fund, Ltd (“Sabby”)
(the “Sabby Agreement”). The amendment and subsequent conversion of the Notes was accounted for as the debt settlement in
equity under ASC 470-60 Troubled Debt Restructurings by Debtors . The Company recognized a gain on extinguishment of $ 6,360 , equal
to the difference between the carrying amount of the Amended Notes at the conversion date, totaling $ 586,360 , and the fair value of the
common stock shares issued to the noteholders of $ 580,000 . This gain on extinguishment is included in other income on the consolidated
statement of operations for the year ended December 31, 2021. For the year ended December 31, 2021 the interest expense on the Notes was
$ 6,360 .
The allocation of the gross proceeds
from the Financing resulted in recording a premium on the Notes of $ 583,349 . The premium is amortized over the term of the Notes. As a
result of the event of default in January 2021 and the Notes becoming due on demand, the Company accelerated the amortization of the premium
and discount and amortized the remaining balances during the three-month period ended March 31, 2021. The Company recognized the amortization
of the premium of $ 145,837 as a reduction to non-cash interest expense during the year ended December 31, 2021. The premium amortization
was included within interest income (expense) on the consolidated statements of operations.
In connection with the Financing, the
Company paid $ 183,194 in issuance costs of which $ 91,597 was recorded as a discount on the Notes and is being amortized over the term
of the Notes. The remaining $ 91,597 was netted with the proceeds allocated to Series A (see Note 7). The Company recognized the amortization
of the discount of $ 22,899 as non-cash interest expense during the year ended December 31, 2021. The discount amortization was included
in the interest income (expense) on the consolidated statements of operations.
2020 Subordinated Notes
On October 22, 2020, the Company issued
$ 154,000 in subordinated promissory notes (“Subordinated Notes”) to the Company’s stockholders, including $ 30,000 to
Lana Management and Business Research International, LLC (“LMBRI”). The Subordinated Notes accrued interest at 8 % payable
at each quarter end and had a maturity date of March 31, 2021. The Company defaulted on the Subordinated Notes on March 31, 2021, and
the Subordinated Notes started to accrue 15 % penalty interest starting on the date of default. For the year ended December 31, 2021 interest
expense on the Subordinated Notes was $ 7,443 . In conjunction with the issuance of the Subordinated Notes, the Company issued to each noteholder
warrants to purchase shares of the Company’s common stock (“Subordinated Note Warrants”) totaling 4,846,688 Common Stock
Warrants, of which 944,160 were issued to LMBRI. The allocation of the proceeds to the Subordinated Note Warrants resulted in a discount
to the Subordinated Notes of $ 148,892 . The Company amortized this discount through non-cash interest expense using the effective interest
method, of which $ 83,752 was amortized during the year ended December 31, 2021, and included in the interest income (expense) in the consolidated
statement of operations.
On June 7, 2021, the holders of $ 132,383
in principal of the Subordinated Notes elected to exercise their warrants into 4,166,357 shares of common stock, with the principal from
the Subordinated Notes applied to the exercise price of the warrants. The remaining $ 21,617 principal amount of the Subordinated Notes
was repaid in cash in 2021.
5. CONVERTIBLE DEBENTURES
On June 7, 2021, the Company entered
into a Securities Purchase Agreement with Sabby, under which the Company committed to sell, and Sabby agreed to purchase, an aggregate
of $ 4,500,000 principal amount of debentures, of which $ 3,000,000 upon execution of the agreement and the remaining $ 1,500,000 within
three trading days of the later of (i) the date that the Company files the Registration Statement with the SEC and (ii) the date that
the Company files the registration statement registering the shares of common stock to be issued in the IPO.
F- 13
On June 8, 2021, the Company issued
a total of $ 3,000,000 of 7.5 % Senior Secured Convertible Debentures (the “Convertible Debentures”) to Sabby. On August 4,
2021, the Company issued an additional $ 1,500,000 of Convertible Debentures upon the filing of a registration statement in connection
to the IPO, which was filed on July 22, 2021. The Convertible Debentures’ principal amount was convertible, at the holder’s
option, into the Company’s Series D Convertible Preferred Stock (Series D) at $ 1,000 conversion price per share. The Convertible
Debenture was automatically converted into Series D upon the effectiveness of an IPO. For the year ended December 31, 2021, interest expense
on the Convertible Debentures was $ 124,829 .
In connection with the IPO, all of
the Company’s outstanding Convertible Debentures automatically converted into 4,500 shares of Series D Preferred Stock on the IPO
Date. Subsequently, the holder of the 4,500 outstanding shares of Series D Preferred Stock exercised their option to convert their shares
into 4,500,000 shares of common stock.
The Company incurred $ 729,658 in issuance
costs consisting of cash payments and 225,000 warrants (the “Dawson Warrants”) issued to the placement agent for compensation
for their services in relation to the issuance of the Convertible Debentures. The Dawson Warrants are exercisable after May 10, 2022 at
the exercise price of $ 1.25 per share of common stock and have a 5 -year term. The Dawson Warrants were accounted for as equity under ASC
815 – Derivatives and Hedging , and the grant date fair value was estimated to be $ 166,816 using Black-Scholes option pricing
model and is included in issuance costs related to the Convertible Debentures.
The resulting discount is amortized
over the term of the Convertible Debentures using the effective interest method. The Company recognized $ 266,193 of amortization of the
discount during the year ended December 31, 2021, which was included within interest income (expense) in the consolidated statement of
operations. The remaining $ 463,465 of unamortized discount was credited to the capital accounts at the time of conversion.
6. WARRANTS
The following table summarizes information
with regard to warrants outstanding at December 31, 2022:
Shares
Exercisable for
Weighted
Average
Exercise
Price
Weighted Average
Remaining
Life
(in Years)
Common Stock Warrants
811,882
Common Stock
$ 3.24
3.1
Class A Warrants
2,484,000
Common Stock
$ 7.00
3.8
Class B Warrants
75,400
Common Stock
$ 10.00 1
3.8
1 Class B Warrants may also exercise such warrants on a “cashless”
basis. See Class A Warrants and Class B Warrants subsection below.
No warrants were issued during the
year ended December 31, 2022. The following assumptions were used in the Black-Scholes option pricing model to estimate the fair value
of the warrants granted during the year ended December 31, 2021:
Risk-free interest rate
0.37 % - 0.73 %
Dividend rate
0 %
Volatility
106.00 % - 142.46 %
Expected life (in years)
5
F- 14
Common Stock Warrants
In March 2021, the Company granted
a financial advisor warrants to purchase 226,599 shares of the Company’s common stock (the “Advisor Warrants”) as consideration
for services in connection with the IPO. The warrants are exercisable at any time from the issuance date at the exercise price of $ 3.177
per share of common stock, subject to adjustment based on the amounts raised in the IPO, and have a 5 -year term. These warrants were accounted
for as equity and the grant date fair value was estimated to be $ 180,339 and were netted against the IPO proceeds. The terms of the advisory
services agreement also provide for an incentive bonus of $ 200,000 payable upon closing of the IPO if such a closing occurs on or before
January 31, 2022. This amount was netted against the IPO proceeds. As of December 31, 2022 and 2021, all of the Advisor Warrants remained
outstanding.
In August 2021, the Company granted
the Dawson Warrants to its placement agent for compensation for their services in relation to the issuance of the Convertible Debentures
(see Note 5). As of December 31, 2022 and 2021, all of the Dawson Warrants remained outstanding.
In November 2021, the Company granted
108,000 warrants (the “Underwriter Warrants”) with an exercise price of $ 12.50 , and a fair value of approximately $ 356,000 ,
to the underwriter of the IPO which is in addition to the cash fees paid for underwriting the Company’s IPO. As of December 31,
2022 and 2021, all of the Underwriter Warrants remained outstanding.
In October 2020, in conjunction with
the issuance of the Subordinated Notes, the Company granted 4,846,688 warrants (the “Subordinated Note Warrants”) to the noteholders,
of which 944,160 were issued to LMBRI (see Note 4). In November 2021, the terms of some of the Subordinated Note Warrants were amended
to provide for cashless exercise. During 2021, 4,718,251 of the Subordinated Note Warrants were exercised. As of December 31, 2022 and
2021, 128,438 of the Subordinated Note Warrants were outstanding.
Class A Warrants and Class B
Warrants
In conjunction with the Company’s
IPO as described in Note 1 the Company issued 2,160,000 Class A Warrants and 2,160,000 Class B Warrants. Additionally, the underwriter
of the IPO exercised their overallotment option, solely with respect to the Class A Warrants and Class B Warrants, shortly after the IPO
Date resulting in an additional issuance of 324,000 Class A Warrants and 324,000 Class B Warrants. From the net IPO proceeds, $ 5,164,751
and $ 7,323,161 , respectively, were apportioned to the Class A Warrants and Class B Warrants.
Class A Warrants entitle the holder
to purchase one share of common stock at an exercise price of $ 7.00 per share. As of December 31, 2022 and 2021 all Class A Warrants were
outstanding.
Class B Warrants entitle the holder
to purchase one share of common stock at an exercise price of $ 10.00 per share. Holders of Class B Warrants may also exercise such warrants
on a “cashless” basis after the earlier of (i) 10 trading days from closing date of the offering or (ii) the time when $10.0
million of volume is traded in the Company’s common stock, if the volume weighted average price of the Company’s common stock
on any trading day on or after the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to
adjustment as described in the warrant agreement). During 2022 and 2021, respectively, 40,100 and 2,368,500 Class B Warrants were exercised,
all on a cashless basis. As of December 31, 2022 and 2021, respectively, 75,400 and 115,500 Class B Warrants were outstanding.
Warrants for Series B Redeemable,
Convertible Preferred Stock
The 643 Series B Warrants (defined
below) issued in conjunction with the Series B redeemable, convertible preferred stock (see Note 7) were accounted for as a derivative
liability under ASC 480 – Distinguishing Liabilities from Equity. On June 1, 2021, the Series B Warrants were amended (“Amended
Series B Warrants”) to become exercisable into 115,190 shares of common stock at an exercise price of $ 2.30 per share and are now
reflected as common stock warrants in the table of outstanding warrants above. The Amended Series B Warrants were accounted for as equity
and reclassified from liabilities into additional paid-in capital at the fair value determined as of the amendment date of $ 145,953 .
F- 15
The fair value of the outstanding the
Amended Series B Warrants at June 1, 2021 was based on the assumptions as follows:
June 1,
2021
Risk-free interest rate
0.31 % - 0.56 %
Dividend rate
0 %
Volatility
88.60 %
Expected life (in years)
2.81 – 4.22
7. PREFERRED STOCK
In 2017 in connection with the Financing
(see Note 4), the Company issued 10,600 shares of Series A. The allocation of proceeds from the Financing was based on the relative fair
values of the Notes and Series A resulting in the Series A being recorded at $ 476,651 , net of $ 91,597 of issuance costs. Series A were
being accreted to the redemption value through December 31, 2021, the redemption date. Accretion of Series A to redemption value, including
the accretion of dividends and issuance costs, was $ 73,912 for year ended December 31, 2021.
In 2019, the Company entered into Subscription
Agreements, as amended, for the issuance of 4,455 shares of Series B plus the committed future issuance of 415 of additional shares (the
“Series B Financing”). The Series B Financing also resulted in the issuance of a total of 848 warrants (the “Series
B Warrants”). Series B were subject to accretion to the redemption value through the redemption date. Accretion of Series B to redemption
value, including the accretion of dividends and issuance costs, was $ 33,993 for the year ended December 31, 2021.
On November 19, 2020, the Company entered
into a Subscription Agreement for the issuance of Series C redeemable, convertible preferred stock (the “Series C Financing”)
with Toray. In connection with the Series C Financing, the Company issued 636 shares of Series C at a purchase price of $ 1,578.50 per
share. Proceeds from the Series C Financing, net of issuance costs, were $ 994,832 . Series C were being accreted to the redemption value
through December 31, 2021, the redemption date. Accretion of Series C to redemption value, including the accretion of dividends and issuance
costs, was $ 19,961 for the year December 31, 2021.
On June 1, 2021, in connection with
the Sabby Agreement (see Note 5), Series A were converted into 1,668,016 shares of common stock, Series B were converted into 816,226
shares of common stock, and Series C were converted into 100,081 shares of common stock. The conversion was affected through the joint
consent of the Company’s Board of Directors and stockholders and was subject to and in accordance with the terms of the Certificates
of Designation. As a result of the conversion, the temporary equity balances at the conversion date were reclassified into the stockholders’
equity.
On June 7, 2021, the Company filed
a certificate of designation of preferences, rights, and limitations with the state of Delaware for up to 4,500 shares of Series D convertible
preferred stock (“Series D”). In connection with the IPO, all of the outstanding Convertible Debentures automatically converted
into 4,500 shares of Series D on the IPO Date. In November 2021, all Series D was converted into 4,500,000 shares of common stock. There
were no Series D outstanding as of December 31, 2022.
8. STOCK COMPENSATION
Stock Incentive Plans
In 2018, the Company adopted the 2018
Stock Incentive Plan (the “2018 Plan”) for employees, consultants, and directors. The 2018 Plan, which is administered by
the Company’s Board of Directors, permits the Company to grant incentive and nonqualified stock options for the purchase of common
stock, and restricted stock awards. The maximum number of shares of common stock reserved for issuance under the 2018 Plan is 629,440 .
At December 31, 2022 there were 262,269 shares of common stock available for grant under the 2018 Plan.
On July 6, 2021, the Company’s Board of
Directors and stockholders approved and adopted the Bluejay Diagnostics, Inc. 2021 Stock Plan (the “2021 Plan”). A total of
1,960,000 shares of common stock were approved to be initially reserved for issuance under the 2021 Stock Plan. At December 31, 2022 there
were 1,339,721 shares of common stock available for grant under the 2021 Plan.
F- 16
Stock Award Activity
The following table summarizes the status of the
Company’s non-vested restricted stock awards for years ended December 31, 2022:
Non-vested
Restricted Stock Awards
Number of
Shares
Weighted
Average
Grant Date
Fair Value
Outstanding at December 31, 2021
-
$ -
Granted
105,000
1.29
Vested
-
-
Forfeited
( 45,000 )
1.29
Outstanding at December, 2022
60,000
$ 1.29
The following is a summary of stock option activity for the year ended
December 31, 2022:
Number of
Stock
Options
Weighted
Average
Exercise
Price Per
Share
Weighted
Average
Remaining
Contractual
Life in
Years
Aggregate
Intrinsic
Value
Outstanding at December 31, 2021
589,786
$ 1.86
8.3
$ 605,187
Granted
236,279
1.80
Exercised
( 62,944 )
0.46
21,354
Cancelled and forfeited
( 43,286 )
1.86
Outstanding at December 31, 2022
719,835
$ 1.96
6.5
$ 20,578
Exercisable at December 31, 2022
495,101
$ 1.97
7.6
$ 20,578
The weighted average grant date fair
value of options granted during the years ended December 31, 2022 and 2021 was $ 1.42 per share and $ 1.16 per share, respectively. The
Company calculated the grant-date fair value of stock option awards granted during the years ended December 31, 2022 and 2021 using the
Black-Scholes model with the following assumptions:
2022
2021
Risk-free interest rate
1.58 % – 4.35 %
0.78 % – 1.27 %
Expected dividend yield
0.00 %
0.00 %
Volatility factor
102.03 % – 107.36 %
106.00 % – 114.76 %
Expected life of option (in years)
5.40 – 6.00
5.00 – 6.00
Stock-Based Compensation Expense
For the years ended December 31, 2022
and 2021, the Company recorded stock-based compensation expense as follows:
Year ended December 31,
2022
2021
Research and development
$ 64,352
$ 29,543
General and administrative
367,702
17,315
Marketing and business development
950
21,600
Total stock-based compensation
$ 433,004
$ 68,458
F- 17
At December 31, 2022, there was approximately
$ 111,357 of unrecognized compensation expense related to non-vested stock option awards that are expected to be recognized over a weighted-average
period of 2.2 years. At December 31, 2022, there was approximately $ 50,859 of unrecognized compensation expense related to non-vested
restricted stock awards that are expected to be recognized over a weighted-average period of 2.1 years.
9. RELATED PARTY TRANSACTIONS
Lana Management and Business
Research International, LLC
Lana Management and Business Research
International, LLC (“LMBRI”) has board members in common with the Company. The Company and LMBRI entered into an Expense Sharing
Agreement, whereby the Company will reimburse LMBRI monthly for certain shared expenses including insurance, rent, salaries, telephone,
and other miscellaneous expenses. The Company was billed $ 4,000 monthly for these expenses through December 31, 2021. On January 1, 2022,
the Company moved into its own leased facility and no longer shared expenses with LMBRI Such amounts are included in general and administrative
expenses on the accompanying consolidated statements of operations. The Company also issued Subordinated Notes and Warrants to LMBRI in
October 2020 as described in Note 4.
The table below summarizes the amounts
incurred, paid, and balances due to LMBRI as of and for year’s ended December 31, 2022 and 2021.
2022
2021
Expenses from LMBRI
$ -
$ 48,000
Expense Sharing Agreement payments to LMBRI
$ -
$ 171,102
Amounts payable to LMBRI
$ 2,000
$ 2,000
Interest Incurred and Payments on Subordinated Notes to LMBRI (Note 4)
$ -
$ 3,303
NanoHybrids, LLC
In December 2021, the Company entered
into an agreement with NanoHybrids, LLC (“NanoHybrids”) to utilize the Company’s research and development staff and
laboratory facility when available to perform work for NanoHybrids. Any hours worked by Company employees for NanoHybrids is billed to
NanoHybrids at a bill rate of the respective employee’s fully burdened personnel cost plus 10 %. NanoHybrids is wholly owned by the
Company’s Chief Technology Officer. The table below summarizes the amounts earned and due from NanoHybrids for the years ended December
31, 2022 and 2021 and balances due as of December 31, 2022 and 2021:
Year Ended
December 31,
2022
2021
Income from NanoHybrids included in Other Income
$ 163,256
$ -
Cash receipts from NanoHybrids
$ 143,525
$ -
As of December 31,
2022
2021
Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets
$ 19,731
$ -
Toray Industries, Inc.
In June 2022, the Company sold five Symphony analyzers
to the Company’s business partner, Toray, for $ 249,040 , all of which was paid in June 2022. Future sales to Toray are not currently
anticipated.
F- 18
10. SUPPLEMENTAL BALANCE SHEET INFORMATION
Prepaid expenses and other current
assets consist of the following:
December 31,
2022
December 31,
2021
Prepaid insurance
$ 751,979
$ 1,127,062
Prepaid clinical trial expenses
-
160,467
Vendor prepayments
681,218
160,000
Prepaid other
240,283
165,179
Total prepaid expenses and other current assets
$ 1,673,480
$ 1,612,708
Accrued expenses and other current
liabilities consist of the following:
December 31,
2022
December 31,
2021
Accrued personnel costs
$ 533,577
$ 157,938
Accrued other
302,153
181,446
Total accrued expenses and other current liabilities
$ 835,730
$ 339,384
11. PROPERTY AND EQUIPMENT
Property and equipment consisted of
the following at December 31, 2022 and 2021:
December 31,
Depreciable lives
2022
2021
Construction in process
$ 375,466
$ 15,078
Furniture, fixtures, and equipment
3 - 5 years
136,942
24,915
Software
3 years
4,457
4,619
Lab equipment
3 - 5 years
1,268,380
741,591
Leasehold improvements
Life of lease
43,231
-
1,828,476
786,203
Less: accumulated depreciation
( 596,406 )
( 448,837 )
Property and equipment, net
$ 1,232,070
$ 337,366
12. LEASES
The Company primarily enters into lease arrangements
for office and laboratory space. A summary of supplemental lease information is as follows:
Year ended
December 31,
2022
Weighted average remaining lease term – operating leases (in years)
3.7
Weighted average remaining lease term – finance leases (in years)
5.1
Weighted average discount rate
7.0
%
Operating cash flows from operating leases
$
149,770
F- 19
A summary of the Company’s lease assets and liabilities are as
follows:
December 31,
2022
Operating lease right-of-use asset
$ 465,514
Finance lease asset included in property & equipment, net
21,067
Total lease assets
486,581
Current portion of operating lease liability
168,706
Current portion of finance lease liability included in accrued expenses
4,807
Non-current operating lease liabilities
323,915
Non-current finance lease liabilities included in other non-current liabilities
15,823
Total lease liabilities
$ 513,251
A summary of the Company’s estimated operating lease payments
are as follows:
Year
2023
$ 168,706
2024
162,991
2025
100,000
2026
100,000
2027
25,000
Thereafter
-
Total future lease payments
556,697
Less: Imputed interest
64,076
Present value of lease liability
$ 492,621
13. COMMITMENTS AND CONTINGENCIES
Purchase Commitments
In October 2022, the Company entered
into a non-cancelable purchase commitment with an international materials vendor for items needed for both development of the Symphony
product line and also to resell to its customers. This agreement commits the Company to purchase approximately $ 800,000 in goods, of which
50 % was prepaid in 2022. No goods have been received under this arrangement as of December 31, 2022.
The Company had multiple open purchase
commitments with its primary contract manufacturing organization in Japan related to the buildout of a manufacturing line for the IL-6
cartridges for the Symphony device. As of December 31, 2022, the total open non-cancellable commitments for the manufacturing line buildout
totaled approximately $ 375,000 .
As of December 31, 2022, the Company
has entered into other non-cancelable purchase commitments primarily for R&D supplies and key advisory services. The purchase commitments
covered by these agreements are for less than one year and aggregate to approximately $ 700,000 .
Minimum Royalties
As required under the License Agreement
(see Note 3), following the first sale of Cartridges, the Company will also make royalty payments to Toray equal to 15% of the net sales
of the Cartridges for the period that any underlying patents exist or for 5 years after the first sale. Following the first sale, the
Company will pay a one-time minimum royalty of $60,000, which shall be creditable against any royalties owed to Toray in such calendar
year. The Company will pay a minimum royalty of $100,000 in each year thereafter, which are creditable against any royalties owed to Toray
in such calendar year. There were no sales of or revenues from the Cartridges through December 31, 2022.
F- 20
Indemnification
The Company has certain agreements
with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees
to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is
probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues
based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses
related to indemnification issues for any period presented.
14. INCOME TAX
No provision for federal income taxes
has been recorded for the years ended December 31, 2022 and 2021 due to net losses and the valuation allowance established.
Significant components of the Company’s
deferred tax assets are as follows:
As of December 31,
2022
2021
Deferred tax assets:
Net operating losses
$ 3,043,585
$ 1,791,043
Tax credits
190,489
3,659
Intangible assets
66,716
68,564
Capitalized R&D expenses
1,018,165
-
Fixed assets
37,580
-
Other
272,106
97,945
Total deferred tax assets
4,628,641
1,961,211
Valuation allowance
( 4,628,641 )
( 1,934,351 )
Net deferred tax assets
$ -
$ 26,860
Deferred tax liabilities:
Fixed assets
-
( 26,860 )
Net deferred tax assets
$ -
$ ( 26,860 )
A reconciliation of the statutory tax
rates and the effective tax rates for the years ended December 2022 and 2021 is as follows:
Year Ended December 31,
2022
2021
Federal statutory rate
21.00 %
21.00 %
State income taxes, net of federal benefit and tax credits
6.86 %
5.41 %
Change in valuation allowance
( 29.06 )%
( 25.88 )%
Permanent differences
1.20 %
( 0.53 )%
Effective tax rate
0.00 %
0.00 %
The Company regularly assesses the
need for a valuation allowance against its deferred tax assets. In making that assessment, the Company considers both positive and negative
evidence related to the likelihood of realization of the deferred tax assets to determine, based on the weight of available evidence,
whether it is more-likely-than-not that some or all of the deferred tax assets will not be realized. In assessing the realizability of
deferred tax assets, the Company considers taxable income in prior carryback years, as permitted under the tax law, forecasted taxable
earnings, tax planning strategies, and the expected timing of the reversal of temporary differences. This determination requires significant
judgment, including assumptions about future taxable income that are based on historical and projected information and is performed on
a jurisdiction-by-jurisdiction basis.
The Company continues to maintain a
full valuation allowance against its net deferred tax assets. During the years ended December 31, 2022 and 2021, management assessed the
positive and negative evidence in its operations and concluded that it is more likely than not that its deferred tax assets as of December
31, 2022 and 2021 will not be realized given the Company’s history of operating losses. The valuation allowance against deferred
tax assets increased by approximately $ 2.7 million and $ 900,000 and during 2022 and 2021, respectively, related mainly to a full valuation
allowance recorded against capitalized research expenditures, additional net operating losses and tax credits generated in the year.
At December 31, 2022, the Company
had federal net operating loss carryforwards of approximately $ 11.2 million. The Company’s federal net operating losses incurred
prior to 2018 totaling $ 713,000 expire through 2037, while its federal net operating losses incurred in 2018 to 2022 totaling $ 10.5 million
can be carried forward indefinitely.
As of December 31, 2022, the
Company had post-apportioned state net operating losses of $ 10.9 million that can generally be carried forward 20 years and will expire
at various dates through 2042. As of December 31, 2021, the Company had post-apportioned Massachusetts net operating losses of $ 6.3
million that can generally be carried forward 20 years and will expire at various dates through 2041.
The Tax Cuts and Jobs Act resulted in significant changes to the treatment
of research or experimental (“R&E”) expenditures under Section 174. For tax years beginning after December 31, 2021, taxpayers
are required to capitalize and amortize all R&E expenditures that are paid or incurred in connection with their trade or business
which represent costs in the experimental or laboratory sense. Specifically, costs for U.S. based R&E activities must be amortized
over five years and costs for foreign R&E activities must be amortized over 15 years; both using a midyear convention. The Company
has implemented this standard on January 1, 2022, noting that the impact on the Company’s consolidated financial statements was
immaterial.
F-21
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.